FDA.reportPublic FDA data

SohMed Allergy Sinus

Manufacturer
SOHM Inc.
Effective date
2013-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:49

Label at a glance#

ProductSohMed Allergy Sinus
Active ingredientAcetaminophen, Chlorpheniramine maleate, Phenylephrine Hydrochloride
Label structure10 sections

Indications and uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies : headache sinus congestion and pressure nasal congestion itchy, watery eyes runny nose and sneezing minor aches and pains itching of the nose or throat helps decongest sinus openings and passages

Dosage and administration

do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 8 caplets in 24 hours. children under 12 years consult a doctor

Storage and handling

avoid excessive heat and humidity store between 15°-30°C (59°-86°F) See end flap for expiration date and lot number

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever
Chlorpheniramine maleate 2 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies :
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • itchy, watery eyes
    • runny nose and sneezing
    • minor aches and pains
    • itching of the nose or throat
    • helps decongest sinus openings and passages

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product.

Although rare, possible reactions to consumption of acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of the skin. If you are taking this product and develop a rash or other skin reaction, stop taking this product immediately and seek medical attention.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (Certain drugs for depression, pscychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. if you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

In case of over-dose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed (see overdose warning)

  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • do not take more than 8 caplets in 24 hours.
  • children under 12 years
    • consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • avoid excessive heat and humidity
  • store between 15°-30°C (59°-86°F)
  • See end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, sodium lauryl sulphate, edetate disodium, dioctyl sodium sulphosuccinate, polyvinylpyrollidone, gelatin, corn starch, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium benzoate, sodium starch glycolate, stearic acid, purified talc, titanium dioxide, yellow iron oxide.

Question or comments?

OTC - QUESTIONS SECTION

1(856) 2863646

SPL UNCLASSIFIED SECTION

Distributed by : Sohm, Inc.
6920 Knott Ave., Suit A-C,
Buena Park, CA 90621

PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC XXXXXXXXXXX

SohMed™
*Compare to the active ingredients in Tylenol:: Allergy Multi-symptom

Multi-Symptom

Allergy Sinus

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg

• Sneezing • Runny Nose • Congestion

24 Caplets

Principal Display Panel - 24 Caplet Bottle Carton
Principal Display Panel - 24 Caplet Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral TabletPSN1
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1
1046781APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50405-003-242020-01-31C16284748780-19d75b9cf-d4a5-f424-e053-dadaa90a57ceSohMed™ Allergy Sinus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50405-003-24SohMed Allergy Sinus24 in 1 BOTTLE, PLASTICTABLET241
50405-003-24SohMed Allergy Sinus1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50405-003SOHMED ALLERGY SINUS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET [SOHM INC.]1Legacy NDC, 2 package rows20130904_dd237a56-b996-49bd-a6e0-027d316dcb31.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
Chlorpheniramine maleateACTIVE INGREDIENTV1Q0O9OJ9Z1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ1
AcetaminophenACTIVE MOIETY362O9ITL9D1
ChlorpheniramineACTIVE MOIETY3U6IO1965U1
PhenylephrineACTIVE MOIETY1WS297W6MV1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA01
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
GELATININACTIVE INGREDIENT2G86QN327L1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WE1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5Z1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6B1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50405-00350405-003-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
Acetaminophen362O9ITL9DACTIB
Chlorpheniramine maleateV1Q0O9OJ9ZACTIB
Phenylephrine Hydrochloride04JA59TNSJACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
EDETATE DISODIUM7FLD91C86KIACT
DOCUSATE SODIUMF05Q2T2JA0IACT
POVIDONE K90RDH86HJV5ZIACT
GELATIN2G86QN327LIACT
STARCH, CORNO8232NY3SJIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 502 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
TALCTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000POLYETHYLENE GLYCOL 600030IQX730WECAPSULE, DELAYED RELEASE / ORAL35 mgExact identifier — unii candidate
15 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING / ORAL8 mgExact identifier — unii candidate
20 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPOWDER, FOR SUSPENSION / ORAL64 mgExact identifier — unii candidate
42 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJINSERT / VAGINAL147 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, DELAYED RELEASE / ORAL366 mgExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / INTRAVENOUS0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPONGE / TOPICAL5 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000POLYETHYLENE GLYCOL 600030IQX730WETABLET, DELAYED RELEASE / ORAL120 mgExact identifier — unii candidate
15 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTSUSPENSION / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii candidate
20 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
44 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, DELAYED RELEASE / ORAL3.2 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED / ORAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4DROPS / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSOLUTION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZTABLET, EXTENDED RELEASE / ORAL498 mgExact identifier — unii candidate
19 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPOWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
42 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, FOR SUSPENSION / ORAL264 mgExact identifier — unii candidate
42 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZCAPSULE / ORAL270 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
42 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0CAPSULE / ORAL8.2 mgExact identifier — unii candidate
11 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSOLUTION/ DROPS / AURICULAR (OTIC)2 mgExact identifier — unii candidate
19 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii candidate
35 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000POLYETHYLENE GLYCOL 600030IQX730WECAPSULE, EXTENDED RELEASE / ORAL302 mgExact identifier — unii candidate
15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UIMPLANT / INTRAVITREAL1.66 mgExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAMUSCULAR864 mgExact identifier — unii candidate
35 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fc1abe03-01c3-4256-88cc-8f12081ce662dd237a56-b996-49bd-a6e0-027d316dcb312013-08-19WarningsExact identifier
spl id: fc1abe03-01c3-4256-88cc-8f12081ce662
spl set id: dd237a56-b996-49bd-a6e0-027d316dcb31

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.